Status:
RECRUITING
Treatment of Hemophilia A Patients With FVIII Inhibitors
Lead Sponsor:
Emory University
Collaborating Sponsors:
Octapharma
Conditions:
Hemophilia A
Eligibility:
MALE
Brief Summary
This is a non-interventional, multicenter, observational, international study in male persons with haemophilia A who have developed inhibitors to any replacement coagulation factor VIII (FVIII) produc...
Detailed Description
This study will capture different approaches in the management of persons with haemophilia A (HA) and inhibitors. HA is a serious blood coagulation disorder caused by a deficiency in FVIII that result...
Eligibility Criteria
Inclusion
- Male persons with haemophilia A, of any severity, who have a historical inhibitor titer ≥ 0.6 BU/mL, including those who have failed previous immune tolerance induction (ITI) attempt(s)
- Persons undergoing ITI with Nuwiq, octanate, or wilateor undergoing ITI with Nuwiq®, octanate® or wilate® and receiving prophylactic therapy with emicizumab, activated prothrombin complex concentrate (aPCC), or activated recombinant factor VII (rFVIIa)
- Participants or participants' parent(s)/legal guardian(s) must be capable of giving signed informed consent and be able to understand the trial documents
Exclusion
- Participants are excluded from the trial if any coagulation disorder other than haemophilia A is diagnosed
- Partly retrospective patients will be excluded if detailed documentation on treatment, all bleeding episodes, inhibitor titers, and FVIII levels is not available for the retrospective period
Key Trial Info
Start Date :
March 17 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 1 2029
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT04023019
Start Date
March 17 2020
End Date
June 1 2029
Last Update
September 5 2025
Active Locations (2)
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1
Arthur M. Blank Hospital
Atlanta, Georgia, United States, 30329
2
HZRM Hämophilie-Zentrum Rhein Main
Mörfelden-Walldorf, Germany, 64546